NCT05963230

Brief Summary

To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories:

  • Femoral Nerve (Femoral)
  • Interpectoral (PECS I) and pectoserratus (PECS II)
  • Transversus abdominis plane (TAP)
  • Serratus Plane (SP)
  • Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

20 days

First QC Date

July 19, 2023

Last Update Submit

March 27, 2024

Conditions

Ultrasound Recordings

Outcome Measures

Primary Outcomes (1)

  • Ultrasound scan recordings

    Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.

    6 months

Study Arms (1)

Volunteer Participants

Healthy adult (18+ years old) volunteers

Other: Ultrasound scans

Interventions

Ultrasound scansOTHER

Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.

Volunteer Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers from the San Diego, California, USA region.

You may qualify if:

  • Male or female, at least 18 years of age;
  • Able to comprehend and sign the Informed Consent prior to enrolment in the study.

You may not qualify if:

  • Aged \<18 years of age;
  • Unwilling or unable to provide informed consent.
  • Previous history of medical interventions that may affect the anatomy of the chosen scan areas, e.g. hip replacements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taylor Research

San Diego, California, 92108, United States

Location

Study Officials

  • James Bowness, Dr

    Intelligent Ultrasound

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

July 1, 2023

Primary Completion

July 21, 2023

Study Completion

July 21, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)